MAUDE Adverse Event Report: COOK MEDICAL SILICONE MALECOT CATHETER

Lot Number U2438296

Device Problem Break (1069)

Patient Problems Fistula (1862); Device Embedded In Tissue or Plaque (3165)

Event Date 12/07/2015

Event Type  Injury  

Event Description

Pt was admitted to the surgery center for exam under anesthesia.Md determined that there was an anal fistula, fistulotomy performed, md requested silicone malecot catheter for placement, to be removed by md at a later date.Center was notified by the md that during removal of the catheter, the tip broke off and was left in the pt.The tip of the catheter had to be surgically removed.The center's purchasing coordinator notified qa manager and contacted the product mfr/ rep.All other silicone malecot catheters removed from stock at this time.Md notified surgery center of event the week of (b)(6) of the event.Dates of use: (b)(6) 2015 - (b)(6) 2015.

• Brand Name: SILICONE MALECOT CATHETER
• Type of Device: SILICONE MALECOT CATHETER
• Manufacturer (Section D): COOK MEDICAL
• MDR Report Key: 5344465
• MDR Text Key: 35099694
• Report Number: MW5058884
• Device Sequence Number: 1
• Product Code: FEW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: U2438296
• Other Device ID Number: G16923
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR